Novel Epidermal Recording and Detection of Seizures (NERDS)
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|ClinicalTrials.gov Identifier: NCT02451618|
Recruitment Status : Recruiting
First Posted : May 22, 2015
Last Update Posted : November 10, 2016
|Condition or disease|
|Seizures Encephalopathy Asphyxiated Newborn|
Infants admitted to our NICU that require a standard EEG for clinical diagnosis will be approached for consent to test one of two new methods of EEG recording. Patients will be randomized to the new epidermal electronic system (EES) or the a hydrogel EKG electrode. All patients will continue to receive the standard of care EEG monitoring.
EES is slim new temporary tattoo technology that can easily be applied to the skin without requiring a technician or scrubbing and preparation as with standard EEG lead. The hydrogel EKG are FDA approved leads normally used to detect cardiac rhythm.
- To compare the rate of detection of neonatal seizures between a new method of recording electrical brain rhythms (EES or EKG) and the current standard of care (EEG, or electroencephalography.)
- To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2018|
Epidermal Electronic System
EES, wireless tattoo electrode
EKG electrode, looking at hairline placement of electrodes.
- Seizure detection [ Time Frame: 24 hours ]Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.
- EEG characterization [ Time Frame: 24 hours ]Compare quality of brain activity with study leads vs standard leads
- Skin integrity from standard EEG vs study electrodes [ Time Frame: 24 hours ]Photographs will be taken to compare skin integrity after each electrode use.
- Hair removal from standard EEG vs study electrodes [ Time Frame: 24 hours ]If hair removal is necessary for study electrode placement.
- Apgar scores [ Time Frame: Birth to 10 minutes of life ]Apgars at 1, 5, 10, 15, and 20 minutes of life if applicable
- Subject received hypothermia treatment within 6 hours of life [ Time Frame: Within 6 hours of life for 72 hours duration ]
- Cause of seizure if known [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 10 days. ]Date and time of seizures and etiology
- Anticonvulsant medication(s) subject received [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 10 days. ]Phenobarbital, Levetiracetam, Phosphenytoin, Versed, Blinded Study Drug, Other
- Gestational age [ Time Frame: At birth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451618
|Contact: Mary J Harbert, MD||858 firstname.lastname@example.org|
|United States, California|
|Sharp Mary Birch Hospital for Women and Newborns||Recruiting|
|San Diego, California, United States, 92123|
|Contact: Mary J Harbert, MD 858-939-4988 email@example.com|
|Contact: Deborah Petruzzelli, BSN 858 939-4891 firstname.lastname@example.org|
|Principal Investigator:||Mary J Harbert, MD||Sharp Mary Birch Hospital for Women and Newborns|